Clinical trial · Observational
Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer
NCT03568981CI-TRIAL-00033447unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aim to investigate the effect of 5-fraction stereotactic partial breast irradiation and whole breast irradiation on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis in early-stage breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial breast irradiation | Radiation | — | UNRESOLVED |
| Whole breast irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Partial Breast Irradiation (PBI)
- description
- Patients receiving 5-fraction stereotactic partial breast irradiation for breast cancer
- interventionNames
- Radiation: Partial breast irradiation
- label
- Whole Breast Irradiation (WBI)
- description
- Patients receiving whole breast irradiation for breast cancer
- interventionNames
- Radiation: Whole breast irradiation
Primary outcomes (12)
- measure
- Change of patient reported psychosocial functioning score
- timeFrame
- Before radiotherapy (allowed to 8 weeks before radiotherapy)
- description
- Patient reported psychosocial functioning measured in 7 point Likert scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS) * Women who underwent breast-conservating surgery and have a plan to undergoing partial or whole breast irradiation * Good performance status (ECOG 0-1) Exclusion Criteria: * Recurrent breast cancer * History of ipsilateral breast irradiation * Positive resection margin status after breast surgery
References
Publications (1)
- DERIVEDByun HK, Chang JS, Kim H, Kim J, Han MC, Kim SY, Park RH, Kim CJ, Kim YB. Cosmetic Outcome and Toxicity After Stereotactic Accelerated Partial Breast Irradiation in Early Breast Cancer: A Prospective Observational Cohort Study. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):690-700. doi: 10.1016/j.ijrobp.2023.05.018. Epub 2023 May 17. PMID 37201757